Bolton Medical's Relay Plus System Used in US Trial

October 29, 2009—Bolton Medical (Sunrise, FL) announced the first use of the Relay Plus system in the company's United States Relay clinical trial. The Relay Plus System offers new delivery system features to optimize navigation and is designed for use with the Relay thoracic stent graft. The Relay and Relay NBS (nonbare stent) thoracic stent grafts are indicated for the treatment of main thoracic aortic pathologies such as aneurysms, penetrating ulcers, pseudoaneurysms, and intramural hematomas in adult patients. The Relay Plus system received CE Mark approval in March 2009 and is available in Europe.

According to the company, Nimesh D. Desai, MD, and Grace J. Wang, MD, performed the first case at the University of Pennsylvania Medical Center in Philadelphia. Wilson Szeto, MD, the Relay clinical trial's study investigator at Penn, reported that results at his site have shown no mortalities, no stroke rate, and no vascular complications during the 2.5 years of participation in the trial.

Dr. Desai stated that the procedure was successful, and that the device allowed for easier access to the difficult-toreach thoracic aorta. He added, “The hydrophilic dual-sheath design in the Relay Plus makes this device highly versatile in terms of tight access vessels, and the additional sheath length provides better stability during graft deployment.”

“The Relay Plus system has a spiral support bar, which allows the graft to take the lesser curve without kinking and eliminates the notion of ‘bird-beaking’ gaps and ‘noman’s land,’ ” commented Dr. Wang. “The system also has smaller-caliber devices (22 mm), which allows for repair of patients with smaller-diameter aortas.”